Method and apparatus for providing transcranial magnetic stimulation (TMS) to an individual

ABSTRACT

An apparatus for applying Transcranial Magnetic Stimulation (TMS) to the brain of an individual comprising: a head mount; a plurality of magnet assemblies for releasable mounting on the head mount; each of the magnet assemblies comprises a permanent magnet, and at least one of (i) a movement mechanism for moving the permanent magnet and/or (ii) a magnetic shield shutter mechanism, to provide a rapidly changing magnetic field; and a computerized controller for operating at least one of the movement mechanism and the magnetic shield shutter mechanism of at least one of the magnet assemblies to apply a rapidly changing magnetic field to the brain of the individual, wherein the computerized controller is configured to provide one of intermittent oscillatory stimulation and continuous oscillatory stimulation, to induce weak electric currents in the brain of an individual so as to modify the natural electrical activity of the brain of the individual.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application:

(1) is a continuation-in-part of prior U.S. patent application Ser. No.14/912,004, filed Feb. 12, 2016 by The Methodist Hospital et al. andSantosh A. Helekar et al. for METHOD AND APPARATUS FOR PROVIDINGTRANSCRANIAL MAGNETIC STIMULATION (TMS) TO AN INDIVIDUAL, which patentapplication:

(A) claims benefit of prior International (PCT) Patent Application No.PCT/US2014/051340, filed Aug. 15, 2014 by The Methodist Hospital forMETHOD AND APPARATUS FOR PROVIDING TRANSCRANIAL MAGNETIC STIMULATION(TMS) TO AN INDIVIDUAL, which patent application in turn:

(i) claims benefit of prior International (PCT) Patent Application No.PCT/US14/27900, filed Mar. 14, 2014 by The Methodist Hospital for METHODAND APPARATUS FOR PROVIDING TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO APATIENT, which claims benefit of prior U.S. patent application Ser. No.13/829,349, filed Mar. 14, 2013 by The Methodist Hospital ResearchInstitute and Santosh A. Helekar et al. for METHOD AND APPARATUS FORPROVIDING TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO A PATIENT; and

(ii) claims benefit of prior U.S. Provisional Patent Application Ser.No. 61/866,447, filed Aug. 15, 2013 by The Methodist Hospital ResearchInstitute and Santosh A. Helekar et al. for METHOD AND APPARATUS FORPROVIDING TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO A PATIENT;

(B) is a continuation-in-part of prior U.S. patent application Ser. No.13/829,349, filed Mar. 14, 2013 by The Methodist Hospital ResearchInstitute and Santosh A. Helekar et al. for METHOD AND APPARATUS FORPROVIDING TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO A PATIENT;

(C) is a continuation-in-part of prior International (PCT) PatentApplication No. PCT/US14/27900, filed Mar. 14, 2014 by The MethodistHospital and Santosh A. Helekar et al. for METHOD AND APPARATUS FORPROVIDING TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO A PATIENT, whichclaims benefit of prior U.S. patent application Ser. No. 13/829,349,filed Mar. 14, 2013 by The Methodist Hospital Research Institute andSantosh A. Helekar et al. for METHOD AND APPARATUS FOR PROVIDINGTRANSCRANIAL MAGNETIC STIMULATION (TMS) TO A PATIENT; and

(D) claims benefit of prior U.S. Provisional Patent Application Ser. No.61/866,447, filed Aug. 15, 2013 by The Methodist Hospital ResearchInstitute and Santosh A. Helekar et al. for METHOD AND APPARATUS FORPROVIDING TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO A PATIENT; and

(2) claims benefit of prior U.S. Provisional Patent Application Ser. No.62/332,087, filed May 5, 2016 by The Methodist Hospital et al. andSantosh A. Helekar et al. for TRANSCRANIAL BRAIN STIMULATION WITHRAPIDLY SPINNING HIGH-FIELD PERMANENT MAGNETS.

The six (6) above-identified patent applications are hereby incorporatedherein by reference.

FIELD OF THE INVENTION

This invention relates to Transcranial Magnetic Stimulation (TMS) ingeneral, and more particularly to novel methods and apparatus forproviding transcranial magnetic stimulation to an individual.

BACKGROUND OF THE INVENTION

Transcranial Magnetic Stimulation (TMS) is a non-invasive procedure inwhich magnetic stimulation is applied to the brain in order to modifythe natural electrical activity of the brain, whereby to provide therapyto an individual, to assist in diagnosis and/or to map out brainfunction in neuroscience research. More particularly, TMS applies arapidly changing magnetic field to the brain of an individual in orderto induce weak electric currents in the brain of the individual throughelectromagnetic induction. These weak electric currents modify thenatural electrical activity of the brain of the individual, whereby toprovide therapy to the individual, to assist in diagnosis and/or to mapout brain function in neuroscience research. TMS has been approved bythe Food and Drug Administration (FDA) for treating depression. TMS isalso currently being investigated in the management of various otherneurological and psychiatric disorders, including stroke, migraines,Parkinson's disease, tinnitus, autism, schizophrenia, etc. TMS is alsobeing used to study brain function in neuroscience research.

Conventional TMS apparatus generally comprises an electromagnetic coilwhich is fixed in position relative to the head of the individual. Sincethe magnetic field applied to the individual is a function of theconfiguration of the electromagnetic coil, the current passed throughthe electromagnetic coil, and the location of the electromagnetic coilrelative to the individual, the fixed construction of conventional TMSapparatus significantly limits the character of the magnetic field whichcan be applied to the individual, and hence significantly limits the TMStherapy which can be provided to the individual. In addition,conventional TMS apparatus generally utilizes very high electriccurrents in the electromagnetic coil, which raises the risk ofaccidental injury to the individual through electric shocks, burns,seizures, etc.

The present invention addresses the foregoing problems associated withthe prior art by providing an improved method and apparatus forproviding Transcranial Magnetic Stimulation (TMS) to an individual. Inaddition, the present invention also provides additional advantages overconventional TMS, e.g., (i) it comprises a portable, wearable devicethat can be used outside of a medical or research facility, e.g., athome; (ii) individuals can self-administer a prescribed treatmentregimen at home through handheld, or worn, wired or wireless electroniccontrollers; (iii) it comprises multiple magnetic stimulators directableat multiple brain structures which can lead to better treatment,diagnostic testing and/or insight into brain function through its use inneuroscience research; (iv) it comprises multiple magnetic stimulatorsdirectable at a particular brain structure which can be more effectivebecause they can induce current flow in multiple orientations; and (v)it comprises multiple magnetic stimulators which can aggregate theirmagnetic fields for more robust brain stimulation.

SUMMARY OF THE INVENTION

The present invention provides a novel method and apparatus forproviding Transcranial Magnetic Stimulation (TMS) to an individual.Among other things, the present invention comprises the provision anduse of novel TMS apparatus which allows the spatial, strength andtemporal characteristics of the magnetic field generated by the TMSapparatus to be custom tailored for each individual, whereby to provideindividual-specific TMS therapy and/or diagnostic testing. It alsoaffords greater flexibility in open-ended investigations of brainfunction in neuroscience research.

In one form of the invention, there is provided apparatus for applyingTranscranial Magnetic Stimulation (TMS) to an individual, wherein theapparatus comprises:

a head mount for disposition on the head of an individual; and

a plurality of magnet assemblies for releasable mounting on the headmount, wherein each of the magnet assemblies comprises a permanentmagnet, and at least one of (i) a movement mechanism for moving thepermanent magnet and/or (ii) a magnetic shield shutter mechanism, forselectively providing a rapidly changing magnetic field capable ofinducing weak electric currents in the brain of an individual so as tomodify the natural electrical activity of the brain of the individual;

wherein the number of magnet assemblies mounted on the head mount, theirindividual positioning on the head mount, and their selective provisionof a rapidly changing magnetic field is selected so as to allow thespatial, strength and temporal characteristics of the magnetic field tobe custom tailored for each individual, whereby to provideindividual-specific TMS therapy and/or diagnostic testing, as well asgreater flexibility in open-ended investigations of brain function inneuroscience research.

In one preferred form of the invention, each of the magnet assemblies isconfigured to provide a rapidly changing magnetic field of at least500-600 Tesla/second.

In another form of the invention, there is provided a method forproviding Transcranial Magnetic Stimulation (TMS) to an individual, themethod comprising:

providing apparatus comprising:

a head mount for disposition on the head of an individual; and

a plurality of magnet assemblies for releasable mounting on the headmount, wherein each of the magnet assemblies comprises a permanentmagnet, and at least one of (i) a movement mechanism for moving thepermanent magnet and/or (ii) a magnetic shield shutter mechanism, forselectively providing a rapidly changing magnetic field capable ofinducing weak electric currents in the brain of an individual so as tomodify the natural electrical activity of the brain of the individual;

positioning the head mount on the head of the individual, andpositioning a selected number of magnet assemblies on the head mount atselected locations; and

selectively providing a rapidly changing magnetic field with at leastone of the magnet assemblies;

wherein the number of magnet assemblies mounted on the head mount, theirindividual positioning on the head mount, and their selective provisionof a rapidly changing magnetic field is selected so as to custom tailorthe spatial, strength and temporal characteristics of the magnetic fieldfor that individual, whereby to provide individual-specific TMS therapyand/or diagnostic testing, as well as greater flexibility in open-endedinvestigations of brain function in neuroscience research.

In one preferred form of the invention, each of the magnet assemblies isconfigured to provide a rapidly changing magnetic field of at least500-600 Tesla/second.

In another form of the invention, there is provided apparatus forapplying Transcranial Magnetic Stimulation (TMS) to an individual,wherein the apparatus comprises:

a head mount for disposition on the head of an individual; and

a plurality of magnet assemblies mounted on the head mount in apredetermined pattern, wherein each of the magnet assemblies comprises apermanent magnet, and at least one of (i) a movement mechanism formoving the permanent magnet and/or (ii) a magnetic shield shuttermechanism, for selectively providing a rapidly changing magnetic fieldcapable of inducing weak electric currents in the brain of an individualso as to modify the natural electrical activity of the brain of theindividual;

wherein the number of magnet assemblies mounted on the head mount, theirindividual positioning on the head mount, and their selective provisionof a rapidly changing magnetic field is selected so as to allow thespatial, strength and temporal characteristics of the magnetic field tobe custom tailored for each individual, whereby to provideindividual-specific TMS therapy, to assist in diagnosis and/or to mapout brain function in neuroscience research.

In one preferred form of the invention, each of the magnet assemblies isconfigured to provide a rapidly changing magnetic field of at least500-600 Tesla/second.

In another form of the invention, there is provided a method forproviding Transcranial Magnetic Stimulation (TMS) to an individual, themethod comprising:

providing apparatus comprising:

a head mount for disposition on the head of an individual; and

a plurality of magnet assemblies mounted on the head mount in apredetermined pattern, wherein each of the magnet assemblies comprises apermanent magnet, and at least one of (i) a movement mechanism formoving the permanent magnet and/or (ii) a magnetic shield shuttermechanism, for selectively providing a rapidly changing magnetic fieldcapable of inducing weak electric currents in the brain of an individualso as to modify the natural electrical activity of the brain of theindividual;

positioning the head mount on the head of the individual; and

selectively providing a rapidly changing magnetic field with at leastone of the magnet assemblies;

wherein the number of magnet assemblies mounted on the head mount, theirindividual positioning on the head mount, and their selective provisionof a rapidly changing magnetic field is selected so as to custom tailorthe spatial, strength and temporal characteristics of the magnetic fieldfor that individual, whereby to provide individual-specific TMS therapy,to assist in diagnosis and/or to map out brain function in neuroscienceresearch.

In one preferred form of the invention, each of the magnet assemblies isconfigured to provide a rapidly changing magnetic field of at least500-600 Tesla/second.

In another form of the invention, there is provided apparatus forcreating a variable magnetic field in a region of space, the apparatuscomprising:

at least one mount for disposition near the region of space; and

a plurality of magnet assemblies for mounting on the at least one mount,wherein each of the magnet assemblies comprises a permanent magnet, andat least one of (i) a movement mechanism for moving the permanent magnetand/or (ii) a magnetic shield shutter mechanism, for selectivelyproviding a variable magnetic field in the region of space;

wherein the number of magnet assemblies mounted on the at least onemount, their individual positioning on the at least one mount, and thecharacteristics of their individual variable magnetic fields areselected so as to tailor the spatial, strength and temporalcharacteristics of the variable magnetic field created in the region ofspace.

In another form of the invention, there is provided a method forcreating a variable magnetic field in a region of space, the methodcomprising:

providing apparatus comprising:

at least one mount for disposition near the region of space; and

a plurality of magnet assemblies for mounting on the at least one mount,wherein each of the magnet assemblies comprises a permanent magnet, andat least one of (i) a movement mechanism for moving the permanent magnetand/or (ii) a magnetic shield shutter mechanism, for selectivelyproviding a variable magnetic field in the region of space;

positioning the at least one mount near the region of space, andpositioning a selected number of magnet assemblies on the at least onemount at selected locations; and

for at least one of the magnet assemblies positioned on the at least onemount, selectively moving at least one of the permanent magnet and/orthe magnetic shield shutter mechanism so as to provide a variablemagnetic field in the region of space;

wherein the number of magnet assemblies mounted on the at least onemount, their individual positioning on the at least one mount, and thecharacteristics of their individual variable magnetic fields areselected so as to tailor the spatial, strength and temporalcharacteristics of the variable magnetic field created in the region ofspace.

In another form of the invention, there is provided apparatus forcreating a variable magnetic field in a region of space, the apparatuscomprising:

a permanent magnet for disposition near the region of space; and

at least one of (i) a movement mechanism for moving the permanent magnetso as to create a variable magnetic field in the region of space and/or(ii) a magnetic field shutter mechanism for creating a variable magneticfield in the region of space.

In another form of the invention, there is provided a method forcreating a variable magnetic field in a region of space, the methodcomprising:

providing apparatus comprising:

at least one of (i) a movement mechanism for moving the permanent magnetso as to create a variable magnetic field in the region of space and/or(ii) a magnetic field shutter mechanism for creating a variable magneticfield in the region of space;

positioning the permanent magnet near the region of space; and

selectively moving at least one of the permanent magnet and/or themagnetic shield shutter mechanism so as to provide a variable magneticfield in the region of space.

In another form of the invention, there is provided apparatus forapplying Transcranial Magnetic Stimulation (TMS) to the brain of anindividual, wherein the apparatus comprises:

a head mount for disposition on the head of an individual;

a plurality of magnet assemblies for releasable mounting on the headmount, wherein each of the magnet assemblies comprises a permanentmagnet, and at least one of (i) a movement mechanism for moving thepermanent magnet and/or (ii) a magnetic shield shutter mechanism,whereby to provide a rapidly changing magnetic field; and

a computerized controller for operating at least one of the movementmechanism and the magnetic shield shutter mechanism of at least one ofthe magnet assemblies so as to apply a rapidly changing magnetic fieldto the brain of the individual, wherein the computerized controller isconfigured to operate at least one of the movement mechanism and themagnetic shield shutter mechanism of the at least one of the magnetassemblies so that the at least one magnet assembly provides one fromthe group consisting of intermittent oscillatory stimulation andcontinuous oscillatory stimulation, whereby to induce weak electriccurrents in the brain of an individual so as to modify the naturalelectrical activity of the brain of the individual.

In another form of the invention, there is provided a method forproviding Transcranial Magnetic Stimulation (TMS) to an individual, themethod comprising:

providing apparatus comprising:

a head mount for disposition on the head of an individual;

a plurality of magnet assemblies for releasable mounting on the headmount, wherein each of the magnet assemblies comprises a permanentmagnet, and at least one of (i) a movement mechanism for moving thepermanent magnet and/or (ii) a magnetic shield shutter mechanism,whereby to provide a rapidly changing magnetic field; and

a computerized controller for operating at least one of the movementmechanism and the magnetic shield shutter mechanism of at least one ofthe magnet assemblies so as to apply a rapidly changing magnetic fieldto the brain of the individual, wherein the computerized controller isconfigured to operate at least one of the movement mechanism and themagnetic shield shutter mechanism of the at least one of the magnetassemblies so that the at least one magnet assembly provides one fromthe group consisting of intermittent oscillatory stimulation andcontinuous oscillatory stimulation, whereby to induce weak electriccurrents in the brain of an individual so as to modify the naturalelectrical activity of the brain of the individual;

positioning the head mount on the head of the individual, andpositioning a selected number of magnet assemblies on the head mount atselected locations; and

selectively providing a rapidly changing magnetic field with at leastone of the magnet assemblies.

In another form of the invention, there is provided apparatus forapplying Transcranial Magnetic Stimulation (TMS) to an individual,wherein the apparatus comprises:

a head mount for disposition on the head of an individual;

a plurality of magnet assemblies mounted on the head mount in apredetermined pattern, wherein each of the magnet assemblies comprises apermanent magnet, and at least one of (i) a movement mechanism formoving the permanent magnet and/or (ii) a magnetic shield shuttermechanism, whereby to provide a rapidly changing magnetic field; and

a computerized controller for operating at least one of the movementmechanism and the magnetic shield shutter mechanism of at least one ofthe magnet assemblies so as to apply a rapidly changing magnetic fieldto the brain of the individual, wherein the computerized controller isconfigured to operate at least one of the movement mechanism and themagnetic shield shutter mechanism of the at least one of the magnetassemblies so that the at least one magnet assembly provides one fromthe group consisting of intermittent oscillatory stimulation andcontinuous oscillatory stimulation, whereby to induce weak electriccurrents in the brain of an individual so as to modify the naturalelectrical activity of the brain of the individual.

In another form of the invention, there is provided a method forproviding Transcranial Magnetic Stimulation (TMS) to an individual, themethod comprising:

providing apparatus comprising:

a head mount for disposition on the head of an individual;

a plurality of magnet assemblies mounted on the head mount in apredetermined pattern, wherein each of the magnet assemblies comprises apermanent magnet, and at least one of (i) a movement mechanism formoving the permanent magnet and/or (ii) a magnetic shield shuttermechanism, whereby to provide a rapidly changing magnetic field; and

a computerized controller for operating at least one of the movementmechanism and the magnetic shield shutter mechanism of at least one ofthe magnet assemblies so as to apply a rapidly changing magnetic fieldto the brain of the individual, wherein the computerized controller isconfigured to operate at least one of the movement mechanism and themagnetic shield shutter mechanism of the at least one of the magnetassemblies so that the at least one magnet assembly provides one fromthe group consisting of intermittent oscillatory stimulation andcontinuous oscillatory stimulation, whereby to induce weak electriccurrents in the brain of an individual so as to modify the naturalelectrical activity of the brain of the individual;

positioning the head mount on the head of the individual; and

selectively providing a rapidly changing magnetic field with at leastone of the magnet assemblies.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIGS. 1 and 2 are schematic views illustrating novel apparatus forproviding Transcranial Magnetic Stimulation (TMS) to an individual;

FIG. 2A is a schematic view showing a TMS stimulation pattern whichcomprises intermittent oscillatory stimulation, wherein “packets” ofmagnetic stimulation are separated by periods of substantial “quiet”;

FIG. 3 is a schematic view illustrating how selective ones of the magnetassemblies of the TMS apparatus of FIGS. 1 and 2 may be activated atselected times so as to provide intermittent oscillatory stimulation TMStherapy to an individual, diagnostic testing and/or investigativeprotocol in neuroscience research;

FIG. 3A is a schematic view showing a TMS stimulation pattern whichcomprises continuous oscillatory stimulation, wherein “wavy” stimuli aredelivered throughout the duration of a stimulation session;

FIG. 3B is a schematic view illustrating how selective ones of themagnet assemblies of the TMS apparatus of FIGS. 1 and 2 may be activatedat selected times so as to provide continuous oscillatory stimulationTMS therapy to an individual, diagnostic testing and/or investigativeprotocol in neuroscience research;

FIG. 4 is a schematic view illustrating the physics of magneticstimulation in a conductor;

FIG. 5 is a schematic view illustrating the biophysics of magneticstimulation of a brain;

FIG. 6 is a table illustrating some of the advantages of the presentinvention over conventional TMS;

FIG. 6A is a schematic view illustrating a spoked wheel for mounting oneor more magnets to the drive shaft of a motor;

FIGS. 6B and 6C are schematic views illustrating slotted wheels formounting one or more magnets to the drive shaft of a motor;

FIG. 6D is a schematic view illustrating various stimulation patternswhich may be produced with the constructions shown in FIGS. 6A-6C;

FIG. 7 is a schematic view illustrating alternative apparatus forproviding TMS to an individual;

FIGS. 8 and 9 are schematic views illustrating novel apparatus forproviding TMS to an individual, wherein the magnet assemblies comprisemagnet shield shutter mechanisms for tailoring the magnetic stimuliapplied to the brain of an individual;

FIG. 10 is a schematic view illustrating voltage fluctuations createdthrough the use of the magnet shield shutter mechanism shown in FIGS. 8and 9;

FIG. 11 is a schematic view illustrating another form of magnet shieldshutter mechanism;

FIG. 12 is a schematic view illustrating still another form of magnetshield shutter mechanism; and

FIG. 13 is a schematic view illustrating novel apparatus for providingTMS to an individual, wherein the magnet assemblies further comprise aservomotor for changing the orientation of the rotating permanentmagnet.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Head-MountedTranscranial Magnetic Stimulation (TMS) Apparatus

Looking first at FIGS. 1 and 2, there is shown novel TranscranialMagnetic Stimulation (TMS) apparatus 5 for providing TMS to anindividual. Among other things, and as will hereinafter be discussed,novel TMS apparatus 5 allows the spatial, strength and temporalcharacteristics of the magnetic field generated by the TMS apparatus tobe custom tailored for each individual, whereby to provideindividual-specific TMS therapy, to assist in diagnosis and/or to mapout brain function in neuroscience research.

More particularly, TMS apparatus 5 generally comprises a head mount 10for positioning on the head of an individual, a plurality of magnetassemblies 15 which are releasably mounted to head mount 10, and aplurality of leads 20 for connecting each of the magnet assemblies 15 toa computerized controller 25. Computerized controller 25 may be aself-standing device or, if desired, computerized controller 25 may bewearable, e.g., on a waistband, an armband, etc. Additionally, ifdesired, magnet assemblies 15 may be connected to computerizedcontroller 25 wirelessly, whereby to eliminate the need for leads 20.

In one preferred form of the invention, head mount 10 comprises a soft,form-fitting skull cap adapted to cover the head of the individual whileleaving the face and ears of the individual exposed. Head mount 10 isintended to provide a stable support for the aforementioned magnetassemblies 15, and to that end head mount 10 preferably comprises atextile construct (e.g., woven, braided or knit fibers) that has astable structure but which can breathe (for comfort of the individual).Alternatively, the head mount could be constructed of other materialssuch as soft plastic. Head mount 10 preferably includes a chin strap 30so that the head mount can be fastened onto the head of an individualwith light tension, whereby to ensure that the head mount maintains afixed position on the head of the individual.

As noted above, a plurality of magnet assemblies 15 are releasablymounted to head mount 10. More particularly, magnet assemblies 15 arereleasably mounted to head mount 10 so that the number of magnetassemblies 15, and/or their individual positioning on head mount 10, canbe varied as desired by the clinician or investigator. To this end, headmount 10 preferably comprises a plurality of fastener bases 35 which aredistributed about the outer surface of head mount 10, and each of themagnet assemblies 15 preferably comprises a counterpart fastener connect40 adapted to mate with a fastener base 35, whereby to allow each magnetassembly 15 to be releasably secured to head mount 10 substantiallyanywhere about the surface of the head mount. It will be appreciatedthat, as a result of this construction, it is possible to releasablysecure the desired number of magnet assemblies 15 to head mount 10, atthe desired locations for those magnet assemblies 15, so that the numberof magnet assemblies 15, and/or their positioning on head mount 10, canbe varied as desired by the clinician or investigator.

By way of example but not limitation, head mount 10 may comprise a wovenfabric skull cap covering the skull of the individual, the plurality offastener bases 35 disposed on head mount 10 may each comprise one halfof a conventional hook-and-loop (e.g., Velcro™) fastener, and thefastener connects 40 of the magnet assemblies 15 may each comprise thesecond half of a conventional hook-and-loop (e.g., Velcro™) fastener. Inthis way, each of the magnet assemblies 15 may be releasably fastened toa fastener base 35, and hence to head mount 10. Alternatively, meansother than conventional hook-and-loop (e.g., Velcro™) fasteners (e.g.,mechanical fasteners, snap fasteners, etc.) may be used to releasablysecure magnet assemblies 15 to head mount 10.

In one preferred form of the invention, magnet assemblies 15 eachcomprise a motor 45 and a permanent magnet 50. Permanent magnet 50 ismounted to the drive shaft 55 of motor 45, such that when motor 45 isenergized, permanent magnet 50 will rotate, whereby to provide a rapidlychanging magnetic field about the magnet assembly. In one preferred formof the invention, each of the magnet assemblies 15 comprises a permanentmagnet 50 for selectively providing a rapidly changing magnetic field ofat least 500-600 Tesla/second corresponding to a magnet movement speedof no less than 400 Hertz. As will be appreciated by those knowledgeablein the field of TMS, by applying this rapidly changing magnetic field ofat least 500-600 Tesla/second, corresponding to magnet movement speed ofno less than 400 Hertz, to the brain of an individual, weak electriccurrents can be induced in the neurons of the brain of the individual.These weak electric currents modify the natural electrical activity ofthe brain of the individual, whereby to provide therapy to theindividual, to assist in diagnosis and/or to map out brain function inneuroscience research. In one preferred form of the invention, motor 45is a variable speed motor, such that permanent magnet 50 may be rotatedfaster or slower, as desired, whereby to adjust the voltage of theelectric currents induced in the neurons of the brain of the individual,as will hereinafter be discussed in further detail. In one preferredform of the invention, permanent magnet 50 comprises a rare earthmagnet, e.g., a neodymium magnet.

TMS apparatus 5 also comprises a computerized controller 25 forindependently controlling the operation of each of the magnet assemblies15, i.e., turning motors 45 on or off, regulating the speeds of motorrotation, etc. Leads 20 connect computerized controller 25 to each ofthe magnet assemblies 15.

Computerized controller 25 may be configured to provide two differentmodes of TMS stimulation using magnet assemblies 15. These two differentmodes can be characterized as: (i) intermittent oscillatory stimulation,and (ii) continuous oscillatory stimulation.

With intermittent oscillatory stimulation, short bursts (or “packets”)of “wavy” TMS stimuli (“stimulus waves”) are delivered at periodicintervals. In one preferred form of the invention, the stimulus waves oroscillations within each burst or packet have a frequency ofapproximately 400 Hz, although they may have a frequency higher or lowerthan 400 Hz. In one preferred form of the invention, the burst (packet)durations range from approximately 1-500 ms. In one preferred form ofthe invention, the silent intervals between bursts (packets) range fromabout 100-10,000 ms, corresponding to stimulation rates of about 10-0.1Hz. Computerized controller 25 is configured so that the durations andrates of stimulation within a stimulation session can be dynamicallyvaried.

With continuous oscillatory stimulation, the “wavy” stimuli aredelivered throughout the duration of a stimulation session that can lastfrom a few seconds to several minutes. In one preferred form of theinvention, the frequency of the stimulus waves of the continuousoscillatory stimulation is approximately 400 Hz, although they may havea frequency higher or lower than 400 Hz. The frequency of the stimuluswaves can be dynamically varied at fixed periodic or variable intervalsusing pulse width modulation with resultant variation in stimulusstrength.

Both methods of stimulation (i.e., intermittent oscillatory stimulationand continuous oscillatory stimulation) can be implemented separately orsimultaneously in multiple magnet assemblies 15 activated at the sametime. Both sets of stimulus parameters can also be varied independently,for each of several simultaneously-operating magnet assemblies 15attached to the skull cap.

Further details regarding intermittent oscillatory stimulation andcontinuous oscillatory stimulation will now be discussed.

Intermittent Oscillatory Stimulation. In one preferred form of theinvention, and looking now at FIG. 2A, computerized controller 25 isconfigured to operate magnet assemblies 15 so as to provide intermittentoscillatory stimulation. In this form of the invention, computerizedcontroller 25 is configured to selectively cause a motor 45 of at leastone of the magnet assemblies 15 to rotate the permanent magnet 50 ofthat magnet assembly so as to provide TMS to an individual, whereincomputerized controller 25 causes the motor to rotate the permanentmagnet for a stimulus period 56 of a given duration (e.g., 1-500 ms),wherein the stimulus period has a repetition rate of a given frequency57 (e.g., 0.1-10 Hz), and wherein, during the stimulus period, thecomputerized controller causes the motor to rotate the permanent magnetat a particular rate of speed 58 (e.g., preferably no less than 400Hertz). This mode of operation causes an actuated magnet assembly toprovide a TMS stimulation pattern to the individual which consists of“packets” 59 of magnetic stimulation (i.e., the duration of whichconstitutes the “stimulus duration” 56) which are separated from oneanother by periods of substantial “quiet” 61 (i.e., the duration of suchperiods of quiet 61 constitutes the “repetition rate” 57 of the stimuluspackets), wherein each of the “packets” 59 of magnetic stimulationconsists of a series of discrete pulses 62 (i.e., the frequency ofwhich, 58, reflects the rate of rotation of the magnet about the axis ofthe motor).

In essence, in this form of the invention, computerized controller 25turns on the motor 50 of a magnet assembly 55, initiating the creationof a “packet” 59 of magnetic stimulation, thereafter turns off the motorof that magnet assembly so as to initiate a period of substantial“quiet” 61, thereafter turns on the motor again so as to create asubsequent “packet” 59 of magnetic stimulation, thereafter turns off themotor of that magnet assembly again so as to initiate a subsequentperiod of substantial “quiet” 61, etc.

It will be appreciated that inasmuch as the starting and stopping of amotor may not be instantaneous, the leading and trailing portions of a“packet” 59 of magnetic stimulation may be tapered somewhat, e.g., suchas is shown in FIG. 2A at 63 and 64, respectively.

Seen in a more global sense, each of the “packets” 59 of magneticstimulation can themselves be considered to be “pulses” 59 of a givenduration (i.e., the “stimulus duration” 56) separated by periods of“quiet” 61 and repeating with a given frequency 57 (i.e., the“repetition rate”). See also FIG. 3, which shows each of the “packets”59 of magnetic stimulation as a single “pulse” 59 along a trace line.

In practice, and as also seen in FIG. 3, computerized controller 25simultaneously coordinates the operation of numerous magnetic assemblies15 so as to coordinate their respective pulses 59, whereby to apply thedesired TMS stimulation to the individual.

Continuous Oscillatory Stimulation. In another preferred form of theinvention, and looking now at FIGS. 3A and 3B, computerized controller25 is configured to operate magnet assemblies 15 so as to providecontinuous oscillatory stimulation. In this form of the invention,computerized controller 25 is configured to selectively cause a motor 45of at least one of the magnet assemblies 15 to rotate the permanentmagnet 50 of that magnet assembly so as to provide TMS to an individual,wherein computerized controller 25 causes the motor to rotate in acontinuous oscillatory manner, so that the “wavy” stimuli are deliveredthroughout the duration of a stimulation session that can last from afew seconds to several minutes. In one preferred form of the invention,the frequency of stimulus waves is approximately 400 Hz, although theymay have a frequency higher or lower than 400 Hz. The frequency of thestimulus waves can be dynamically varied at fixed periodic or variableintervals using pulse width modulation with resultant variation instimulus strength.

Thus, in accordance with the present invention, a clinician orinvestigator first determines, for each individual, (i) how many magnetassemblies 15 should be mounted to head mount 10, (ii) where thosemagnet assemblies 15 should be mounted on head mount 10, (iii) whenvarious magnet assemblies 15 should have their permanent magnets 50rotated, and (iv) the speed of such rotation, in order to preciselytailor the spatial, strength and temporal characteristics of themagnetic field which is generated by TMS apparatus 5, whereby to providethat individual with individual-specific TMS therapy, to assist indiagnosis and/or to map out brain function in neuroscience research.

Thereafter, when TMS therapy and/or testing is to be applied to theindividual, the individual puts on head mount 10, the clinician orinvestigator mounts the appropriate number of magnet assemblies 15 tohead mount 10, positioning those magnet assemblies at the appropriatelocations on head mount 10, and then computerized controller 25thereafter controls which magnet assemblies 15 have their magnetsrotated when, and at what speed (i.e., computerized controller 25thereafter controls which magnet assemblies 15 produce stimulationpulses 62 and the respective timing of those stimulation pulses 62 and,where the TMS therapy is to use intermittent oscillatory stimulation,the grouping of those stimulation pulses 62 and the separation betweenthe grouping of those stimulation pulses 62). In this way, the spatial,strength and temporal characteristics of the magnetic field generated byTMS apparatus 5 can be precisely tailored according to each individual'sneeds, whereby to provide individual-specific TMS therapy to theindividual, to assist in diagnosis and/or to map out brain function inneuroscience research.

See, for example, FIG. 3, which shows how selected magnet assemblies 15,located at various locations about head mount 10, may have theirrespective permanent magnets rotated at different times, i.e., so as toprovide a desired spatially-tailored and temporally-tailored pulsepattern. In this respect it will be appreciated that as the permanentmagnet of a particular magnetic assembly 15 is rotated, it will apply arapidly changing magnetic field to the individual, and this changingmagnetic field is a function of the size and strength of the permanentmagnet 50 of that magnet assembly and the rate at which the permanentmagnet is rotated.

See also, for example, FIG. 4, which illustrates the physics of magneticstimulation in a conductor, and FIG. 5, which illustrates the rapidvoltage fluctuations recorded during magnetic stimulation of a singlesite on the head of an individual (note that the electrical responsesshown in FIG. 5 may also include electrical responses in the electrodewires).

Furthermore, it will be appreciated that the rapidly changing magneticfields produced by the plurality of magnetic assemblies 15 located onhead mount 10 together aggregate into a complex, composite, rapidlychanging magnetic field which varies across the brain of the individual,both spatially and temporally, according to the positions of the magnetassemblies 15 on head mount 10 and the relative timings of theirrespective magnet rotations.

Thus it will be seen that with the novel TMS apparatus 5 of the presentinvention, the clinician or investigator may custom tailor the spatial,strength and temporal characteristics of the magnetic field generated bythe TMS apparatus 5 for each individual, whereby to provideindividual-specific TMS therapy, to assist in diagnosis and/or to mapout brain function in neuroscience research.

Significantly, the present invention comprises a portable, wearabledevice that can be used outside of a medical or research facility, e.g.,at home. Furthermore, individuals can self-administer a prescribedtreatment regimen at home through handheld, or worn, wired or wirelesselectronic controllers.

It should be appreciated that, inasmuch as the present inventioncomprises multiple magnetic stimulators directable at multiple brainstructures, it can be possible to achieve better treatment, diagnostictesting and/or insight into brain function through its use inneuroscience research.

Also, inasmuch as the present invention comprises multiple magneticstimulators directable at a single brain structure, it can be possibleto achieve superior results because they can induce current flow inmultiple orientations.

Furthermore, inasmuch as the present invention comprises multiplemagnetic stimulators which can aggregate their magnetic fields for morerobust brain stimulation, it can be possible to achieve bettertreatment, diagnostic testing and/or insight into brain function throughits use in neuroscience research. Among other things, this more robustbrain stimulation can relate to which regions of the brain arestimulated, the orientation(s) of the current flow induced in theregions which are stimulated, the magnitudes of the current flow inducedin the regions which are stimulated, and the timings of suchstimulation.

In accordance with the present invention, there is also provided a novelmethod for determining how many magnet assemblies 15 should be mountedto head mount 10, where those magnet assemblies 15 should be mounted onhead mount 10, when various magnet assemblies 15 should have theirmagnets rotated, and the speed of such magnet rotation, in order toprecisely tailor the spatial, strength and temporal characteristics ofthe magnetic field which is to be applied to that individual, whereby toprovide that individual with individual-specific TMS therapy, to assistin diagnosis and/or to map out brain function in neuroscience research.More particularly, in accordance with the present invention, head mount10 may include a plurality of electrodes 60 for monitoring changes inthe electrical activity of the brain of the individual. Electrodes 60are preferably connected to computerized controller 25 so that changesin the electrical activity of the brain, monitored by electrodes 60, canbe correlated with variations in the spatial, strength and temporalcharacteristics of the magnetic field being applied to the individual byTMS apparatus 5, which in turn corresponds to the number, location andspeed of rotation of the various magnet assemblies 15. In this way,using a feedback process, changes in the number, location and speed ofrotation of the various magnet assemblies 15 can be correlated tochanges in the electrical activity of the brain of the individual,whereby to create an individual specific TMS therapy, to assist indiagnosis and/or to map out brain function in neuroscience research.

The present invention offers numerous advantages over the prior art.More particularly, the novel TMS apparatus 5 of the present inventionallows the spatial, strength and temporal characteristics of themagnetic field to be custom tailored for each individual, whereby toprovide individual-specific TMS therapy, to assist in diagnosis and/orto map out brain function in neuroscience research. Among other things,the present invention provides the following significant advantages overconventional TMS: (i) it comprises a portable, wearable device that canbe used outside of a medical or research facility, e.g., at home; (ii)individuals can self-administer a prescribed treatment regimen at homethrough handheld, or worn, wired or wireless electronic controllers;(iii) it comprises multiple magnetic stimulators directable at multiplebrain structures which can lead to better treatment, diagnostic testingand/or insight into brain function through its use in neuroscienceresearch; (iv) it comprises multiple magnetic stimulators directable ata particular brain structure which can be more effective because theycan induce current flow in multiple orientations; and (v) it comprisesmultiple magnetic stimulators which can aggregate their magnetic fieldsfor more robust brain stimulation. In addition, the present inventioneliminates the risk of accidental injury to the individual throughelectric shocks, burns, seizures, etc.

See FIG. 6, which lists some of the advantages of the present inventionover conventional TMS apparatus.

Additional Constructions

If desired, the entire outer surface of head mount 10 may be covered bya single large fastener base 35, or major sections of head mount 10 maybe covered by several large fastener bases 35, where the one or morelarge fastener bases 35 receive one or more magnet assemblies 15.

Furthermore, if desired, head mount 10 may be formed as a harness,comprising a plurality of straps which are connected together, but havespacing between the various straps, so as to provide a grid-likestructure about the head. These straps can be formed out of leather,plastic, a textile, etc. In this form of the invention, fastener bases35, and hence magnet assemblies 15, are mounted along the straps whichmake up head mount 10.

It is also possible to mount multiple magnets to the drive shaft of asingle motor. By way of example but not limitation, and looking now atFIG. 6A, a “spoked wheel” 66 may be mounted to the drive shaft 55 of amotor 40 of a magnet assembly 15, wherein the spoked wheel 66 comprisesa plurality of seats 67 (e.g., eight seats 67) to receive magnets 50. Itwill be appreciated that all of seats 67 may receive magnets 50 or onlysome of the seats 67 may receive magnets 50. Furthermore, specific onesof the magnets 50 may be mounted within seats 67 so that their N-polefaces the drive shaft 55, or specific ones of the magnets 50 may bemounted within seats 67 so that their S-pole faces the drive shaft 55.By way of further example but not limitation, and looking now at FIG.6B, a “slotted wheel” 68 may be mounted to the drive shaft 55 of a motor40 of a magnet assembly 15, wherein the slotted wheel 68 comprises aplurality of seats 69 (e.g., eight seats 69) to receive magnets 50.Again, it will be appreciated that all of seats 69 may receive magnets50 or only some of the seats 69 may receive magnets 50. Furthermore,specific ones of the magnets 50 may be mounted within seats 69 so thattheir N-pole faces the drive shaft 55, or specific ones of the magnets50 may be mounted within seats 69 so that their S-pole faces the driveshaft 55. It will be appreciated that the number of seats 67 provided inspoked wheels 66, and/or the number of seats 69 provided in slottedwheels 68 may be varied. See, for example, FIG. 6C, which shows fourseats 69 formed in slotted wheel 68.

In one preferred form of the invention, 8 seats 67 are provided inspoked wheel 66, and 8 seats 69 are provided in slotted wheels 68, sothat magnets 50 may be oriented radially at 45 degree angles withrespect to each other (where adjacent seats 67, or adjacent seats 69,are filled with magnets).

It will be appreciated that spoked wheels 66 and slotted wheels 68enable the user to change the shapes of the stimulus waves provided bymagnet assemblies 15, e.g., such as to better mimic different neuronalbursting patterns. See, for example, FIG. 6D, which shows a variety ofdifferent stimulus patterns which may be provided using spoked wheels 66and/or slotted wheels 68. Some multiple magnet configurations can resultin up to 3-fold greater stimulus strengths without any increase in motorrotation speed.

The spoked wheels 66 and/or the slotted wheels 68 may be made of strong,light plastic and 3D-printed with high precision. Note that where a seat67 of spoked wheel 66 is not filled with a magnet 50, and/or where aseat 69 of slotted wheel 68 is not filled with a magnet 50, anon-magnetized metal rod (of the same shape, size and weight as magnets50) are preferably positioned in the “unfilled” seats 67, 69 so as tokeep the spoked wheel or slotted wheel balanced. Caps (not shown) arepreferably provided to keep magnets 50 (and any non-magnetized metalrods) secured in seats 67, 69.

It will be appreciated that the arrangement of the magnets andnon-magnetized rods can be changed in any specified manner. Similarly,the orientation of the poles of the magnets can also be changed. Thesechanges enable the shape of repeated waves of stimulation to be variedcorrespondingly when the component is rotated by the motor. The variedpositions of the magnets also allow the rise times, and consequently theamplitude, of the stimuli to be varied various ways. The overallmagnetic field configuration varies based on the arrangements andorientations of the magnets, producing up to 3-fold greater stimulusstrengths for some configurations. Mixing and matching of up to 8magnets, each in two different orientations, and non-magnetic rods atdifferent positions in the wheel, generate a repertoire of 834 differentshapes of stimulus waves (see FIG. 6D for various examples).

In addition, if desired, magnet assemblies 15 may be constructed so thatmagnets 50 are moved longitudinally, rather than rotationally, byactuators (e.g., linear actuators) in order to produce a rapidlychanging magnetic field. See, for example, FIG. 7, where the actuatorscomprise solenoids 65 to move magnets 50 rapidly so as to create thechanging magnetic field utilized in the present invention.

Also, if desired, permanent magnets 50 may be replaced by smallelectromagnets, if the requisite high strength magnetic field can beachieved (e.g., so as to provide a rapid change of magnetic flux of atleast 500-600 Tesla/second), and with the appropriate amount of coolingto prevent heating and melting of the magnet coils.

In accordance with the present invention, it is also possible to providea head mount 10 (e.g., a skull cap) which has a predetermined number ofmagnet assemblies 15 already mounted on (or incorporated into) headmount 10 in a predetermined pattern. In this case, the cliniciandetermines which ones of the predetermined, predisposed magnetassemblies 15 should be activated and, for those magnet assemblies whichare to be activated, when they should have their magnets rotated, andthe speed of such rotation, in order to precisely tailor the spatial,strength and temporal characteristics of the magnetic field which is tobe applied to the individual, whereby to provide that individual withindividual specific TMS therapy, to assist in diagnosis, and/or to mapout brain function in neuroscience research. Furthermore, in this formof the invention, it may be desirable to provide a kit of such devices,wherein each device in the kit comprises a head mount 10 (e.g., a skullcap) which has a predetermined number of magnet assemblies 15 alreadymounted on (or incorporated into) head mount 10 in a predeterminedpattern, with each device in the kit providing a different predeterminedpattern of magnet assemblies 15.

System Using High-Speed Shutters to Further Tailor the Magnetic Stimuli

In the foregoing, there is disclosed a novel method and apparatus forproviding transcranial magnetic stimulation (TMS) to the brain of anindividual so as to induce, modulate and/or disrupt neural activity inthe brain of the individual.

In one form of the invention, the apparatus comprises a plurality ofhigh strength (e.g., 1.48 Tesla) neodymium magnets, each attached to ahigh speed motor (or actuator). These magnet assemblies are mounted invarious locations on a EEG-type cap or head mount. The magnet assembliesare interfaced with a computer, and a software program having auser-friendly graphical user interface enables dynamic interaction withthe apparatus by a physician, technician, researcher and/or theindividual themselves. On account of its construction, the apparatus isable to provide tailored magnetic stimulation to the brain, with themagnetic stimulation being tailored according to (i) where the magnetassemblies are located on the EEG-type cap, (ii) which specific magnetassemblies are energized (e.g., which magnets are rotated by theirassociated motors) and when (i.e., so as to spatially and temporallytailor the pulses 62 produced by the magnet assemblies), and (iii) atwhat speed each magnet is rotated by its associated motor. The apparatusis of use in studying brain function in neuroscience research, andpotentially in the diagnosis and/or treatment of variousneuropsychiatric conditions such as depression, stroke rehabilitation,chronic pain and neurodegenerative diseases.

The novel method and apparatus of the present invention providessignificant advantages over traditional approaches for providingTranscranial Magnetic Stimulation (TMS). More particularly, traditionalTMS devices utilize a large coil (i.e., an electromagnet) placed on thesurface of the head of the individual. The present invention's use of aplurality of small but powerful permanent magnets, each independentlypositionable and independently rotatable, enable the apparatus of thepresent invention to generate a magnetic field which is bothtime-varying (e.g., by varying the duration and timing of rapid rotationof the magnets) and spatially-varying (by selecting which magnets arerotated) and strength-varying (by selecting the speed of rotation of themagnets).

A comparison of the magnetic fields generated by the permanent magnetsof the present invention vis-à-vis the typical peak fields ofconventional TMS coils has shown that whereas the penetration depth ofconventional TMS coils is greater than that of the permanent magnets ofthe present invention, the permanent magnet fields of the presentinvention are more localized. The pulse rise time, an equally importantfactor for the amplitude of induced voltages and penetration depth, canpotentially be made comparable by using ultra-fast motors to move thepermanent magnets of the present invention.

Furthermore, by using motors which have very short start and stopdelays, when using intermittent oscillatory stimulation, the stimulation“packets” 59 can have reduced tapering at their beginnings and ends 63and 64, respectively. In other words, each of the pulses (packets) 59can appear more like a “square” wave than a rising/falling wave.

The feasibility of the permanent magnet approach of the presentinvention has been demonstrated by mapping motor areas in humans byrecording the electromyographic response of the thenar muscle. Thenarinduced motor unit potentials were maximized for individually fixedstimulus locations and fell off for stimulation at a distance of 10 mmaway from the peak location, indicating the focusing properties of themild stimuli. Significantly, the present invention's provision of TMSwith permanent magnets, arranged in an array of independent stimulationsites across the cortex, allows for investigations of interdependenciesand spatiotemporal or synchronous modulation of cortical networks ofvarying sizes.

It will be appreciated that the novel method and apparatus discussedabove depends on the provision of a plurality of rapidly-moving,high-strength permanent magnets, positioned and energized (i.e., startedand stopped) as appropriate, so as to deliver the desired magneticstimuli to the brain.

In accordance with the present invention, there is now provided anadditional construction which provides an additional mode of tailoringthe magnetic stimuli applied to the brain of the individual. This newconstruction is particularly useful where intermittent oscillatorystimulation is to be applied, since it provides a way to tailor thestimulation packets 59 without requiring the motor of a magnet assemblyto be started and stopped. More particularly, this new constructioninvolves rapid unshielding and shielding of the magnetic fields of thepermanent magnets using a magnetic shield shutter mechanism. Themagnetic shield shutter mechanism is preferably formed either by usinghigh-speed shutters formed out of a special magnetic shielding materialor by transiently changing the efficacy of a special magnetic shieldingmaterial, wherein the high-speed shutters or the transiently-changingshielding material is interposed between permanent magnets and the brainof the individual.

Significantly, the magnetic shield shutter mechanism of the presentinvention is configured to modulate the magnetic fields of the permanentmagnets, and hence permits stationary or moving permanent magnets to beused with the present invention. This is in contrast to embodimentswhere no magnetic shield shutter mechanism is provided, and hencerequire the use of moving permanent magnets to create the changingmagnetic fields applied to the anatomy. More particularly, where thepermanent magnets are moving, and hence creating a changing magneticfield by virtue of magnet movement, the magnetic shield shuttermechanism can be used to further modulate the changing magnetic fieldcreated by the moving magnet. Correspondingly, where the permanentmagnets are not moving, and hence provide a static magnetic field, themagnetic shield shutter mechanism can be used to modulate the staticmagnetic field provided by the stationary permanent magnet and henceprovide the desired changing magnetic field at an anatomical location.Thus, the magnetic shield shutter mechanism of the present inventionallows either stationary or permanent magnets to be used in the magnetassemblies attached to head mount 10.

Significantly, the magnetic shield shutter mechanism also providesanother way of tailoring the stimulation pulses 59 (i.e., stimulation“packets” 59) without requiring the motor of a magnet assembly to bestarted and stopped. More particularly, in this form of the invention, amotor of a magnet assembly can be run continuously, and the beginning 63and end 64 of a stimulation “packet” 59 can be established byappropriate operation of the magnetic shield shutter mechanism.

By way of example but not limitation, in one form of the invention, themagnet assembly may comprise a moving permanent magnet to provide thedesired changing magnetic field and the magnetic shield shuttermechanism may be omitted; in another form of the invention, the magnetassembly may comprise a stationary permanent magnet and the magneticshield shutter mechanism may be used to provide the desired changingmagnetic field; and in another form of the invention, the magnetassembly may comprise a moving permanent magnet to provide a changingmagnetic field and the magnetic shield shutter mechanism may be used tomodulate the changing magnetic field created by the moving magnet so asto provide a desired changing magnetic field at the anatomical location.

Also, if desired, the permanent magnets may be replaced by smallelectromagnets, if the requisite high strength magnetic field can beachieved (e.g., so as to provide a rapid change of magnetic flux of atleast 500-600 Tesla/second), and with the appropriate amount of coolingto prevent heating and melting of the magnet coils. Thus, by way ofexample but not limitation, in one form of the invention, the magnetassembly may comprise a moving electromagnet to provide the desiredchanging magnetic field and the magnetic shield shutter mechanism may beomitted; in another form of the invention, the magnet assembly maycomprise a stationary electromagnet and the magnetic shield shuttermechanism may be used to provide the desired changing magnetic field;and in another form of the invention, the magnet assembly may comprise amoving electromagnet to provide a changing magnetic field and themagnetic shield shutter mechanism may be used to modulate the changingmagnetic field created by the moving magnet so as to provide a desiredchanging magnetic field at the anatomical location.

In one preferred form of the present invention, each magnet assembly 15is provided with an associated magnetic shield shutter mechanism foradditionally tailoring the magnetic stimuli applied to the brain of theindividual by that magnet assembly 15. And in one preferred form of thepresent invention, each magnet assembly 15 and its associated magneticshield shutter mechanism are configured as a unit, such that when thatmagnet assembly 15 is mounted to head mount 10, its associated magneticshield shutter mechanism is also mounted to head mount 10.

More particularly, and looking now at FIGS. 8 and 9, in one form of thepresent invention, there is provided a magnet shield shutter mechanism100 which comprises a disc 105 formed out of a magnetic shieldingmaterial. By way of example but not limitation, disc 105 may be formedout of Mu-Metal, a nickel-iron alloy composed of approximately 77%nickel, 16% iron, 5% copper and 2% chromium or molybdenum. By way offurther example but not limitation, disc 105 may be formed out ofMagnetShield, a magnetic shield plate available from AdrProVita ofBaltimore, Md., USA. Disc 105 has at least one circular opening 110formed therein. Disc 105 is disposed between stationary or moving magnet50 of a magnet assembly 15 and the brain of the individual. Disc 105 ismounted to the drive shaft 115 of a motor 120, such that motor 120 canbe used to selectively (i) position the magnetic shielding material ofdisc 105 between stationary or moving magnet 50 and the brain of theindividual, whereby to shield the brain of the individual from themagnetic field of the stationary or moving magnet 50, or (ii) positionthe at least one circular opening 110 between stationary or movingmagnet 50 and the brain of the individual, whereby to expose the brainof the individual to the magnetic field of stationary or moving magnet50, or (iii) sweep the at least one circular opening 110 of disc 105 bystationary or moving magnet 50 so as to modulate the magnetic fieldcreated by magnet 50 (i.e., to modulate the static magnetic field of astationary magnet 50 so as to create the desired changing magnetic fieldor to modulate the changing magnetic field of a moving magnet 50 so asto create the desired changing magnetic field). Motor 120 is used toappropriately positioning a desired portion of disc 105 betweenstationary or moving magnet 50 and the brain of the individual.Preferably motor 120 is controlled by the same computerized controller25 which drives magnet assemblies 15.

As seen in FIGS. 8 and 9, magnet assembly 15 and its associated magneticshield shutter mechanism 100 are preferably configured as a unit, withmagnet assembly 15 and its associated magnetic shield shutter mechanism100 being contained in a housing 122, such that when that magnetassembly 15 is mounted to head mount 10 (e.g., by mounting housing 122to head mount 10), its associated magnetic shield shutter mechanism isalso mounted to head mount 10.

FIG. 10 shows how the magnetic field of a magnet assembly 15 may betailored by the magnetic shield shutter mechanism 100 of FIGS. 8 and 9.

If desired, and looking now at FIG. 11, the at least one circularopening 110 may be replaced by at least one slot 110. Alternatively, theat least one circular opening 110 may be replaced by at least oneopening of another configuration.

In another form of the present invention, and looking now at FIG. 12,the magnet shield shutter mechanism 100 comprises a shielding material125 whose magnetic permeability and/or saturation may be rapidly andtransiently changed by an electrically-triggered mechanism so as toeffectively provide a shutter mechanism, whereby to allow tailoring ofthe magnetic stimulus delivered to the individual. See, for example,Sanchez et al., 2011, Antimagnets: controlling magnetic fields withsuperconductor-metamaterial hybrids, New J. Phys., 13, 093034,doi:10.1088/1367-2630/13/9/093034, which discusses shielding materialwhose magnetic permeability and/or saturation may be rapidly andtransiently changed by an electrically-triggered mechanism. In this formof the invention, the transiently-changing shielding material isdisposed between stationary or moving magnet 50 and the brain of theindividual so as to modulate the magnetic field created by magnet 50(i.e., to modulate the static magnetic field of a stationary magnet 50so as to create the desired changing magnetic field or to modulate thechanging magnetic field of a moving magnet 50 so as to create thedesired changing magnetic field). When the brain of the individual is tobe shielded from the magnetic field of stationary or moving magnet 50,the magnetic permeability and/or saturation of shielding material 125 isreduced. Correspondingly, when the brain of the individual is to beexposed to the magnetic field of stationary or moving magnet 50, themagnetic permeability and/or saturation of the shielding material 125 isincreased. The electrically-triggered mechanism is preferably controlledby the same computerized controller 25 which drives the magnetassemblies 15.

As seen in FIG. 12, magnet assembly 15 and its associated magneticshield shutter mechanism 100 are preferably configured as a unit, withmagnet assembly 15 and its associated magnetic shield shutter mechanism100 being contained in housing 122, such that when that magnet assembly15 is mounted to head mount 10 (e.g., by mounting housing 122 to headmount 10), its associated magnetic shield shutter mechanism is alsomounted to head mount 10.

The provision of high-speed shutters in conjunction with the magnetassemblies 15 increases the functionality, capability and efficiency ofthe apparatus. Among other things, it allows single pulses 59 ofmagnetic stimulation with submillisecond rise times to be delivered tothe brain, thereby making it possible to more accurately measure thedelays in onset of responses to the magnetic stimuli in research anddiagnostic settings. One specific diagnostic application of the newmethod would be the measurement of electromyographic induced motor unitpotential responses from different muscle groups, and induced responsesfrom different locations on the scalp and spinal column, upon serialmulti-site stimulation of the motor cortex, to assess the functionalintegrity of the corticospinal tract, and assist in the differentialdiagnosis of upper and/or lower motor neuronal dysfunctions such asAmyotrophic Lateral Sclerosis. The new method also enables moreflexibility and control of the stimulus protocol in potentialtherapeutic applications.

The rapid stimulus delivery can also have diagnostic and therapeuticapplication for stimulation of pathways and structures other than thebrain with single magnet-shutter assemblies. These stimulation sites mayinclude the spinal cord and peripheral nerves and muscles.

Changing the Orientation of the Rotating Permanent Magnet Using aServomotor Mechanism

In some situations it may be desirable to precisely adjust theorientation of magnet assemblies 15, e.g., so as to match the directionof nerve cells/fibers in the cortex and/or to further tailor themagnetic field applied to the anatomy by a specific magnet assemblyand/or to further tailor the aggregated magnetic field applied to theanatomy by the various magnet assemblies attached to head mount 10. Thismay be effected to some extent by adjusting the disposition of magnetassemblies 15 on head mount 10, however, in some circumstances it maynot be possible to achieve the desired precision in orientation, e.g.,due to limitations in the manner in which fastener connect 40 on magnetassemblies 15 mate with fastener base 35 on head mount 10. To this end,and looking now at FIG. 13, motor 45 (for turning permanent magnet 50)may be mounted on the shaft 126 of a servomotor 127, such thatactivating servomotor 127 can allow the axis of rotation of the movingmagnet 50 to be precisely and dynamically changed, e.g., without movinghousing 122 on head mount 10.

Modifications of the Preferred Embodiments

It should be appreciated that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

What is claimed is:
 1. Apparatus for applying Transcranial MagneticStimulation (TMS) to the brain of an individual, wherein the apparatuscomprises: a head mount for disposition on the head of an individual; aplurality of magnet assemblies for releasable mounting on the headmount, wherein each of the magnet assemblies comprises a permanentmagnet, and at least one of (i) a movement mechanism for moving thepermanent magnet and/or (ii) a magnetic shield shutter mechanism,whereby to provide a rapidly changing magnetic field; and a computerizedcontroller for operating at least one of the movement mechanism and themagnetic shield shutter mechanism of at least one of the magnetassemblies so as to apply a rapidly changing magnetic field to the brainof the individual, wherein the computerized controller is configured tooperate at least one of the movement mechanism and the magnetic shieldshutter mechanism of the at least one of the magnet assemblies so as toprovide intermittent oscillatory stimulation and, simultaneously, tooperate at least one of the movement mechanism and the magnetic shieldshutter mechanism of at least one of the magnet assemblies so as toprovide continuous oscillatory stimulation, whereby to induce weakelectric currents in the brain of an individual so as to modify thenatural electrical activity of the brain of the individual.
 2. Apparatusaccording to claim 1 wherein the computerized controller operates atleast one of the movement mechanism and the magnetic shield shuttermechanism of a plurality of the magnet assemblies in a coordinatedfashion so as to induce the desired weak electric currents in the brainof an individual so as to modify the natural electrical activity of thebrain of the individual.
 3. Apparatus according to claim 1 wherein eachof the magnet assemblies is configured to provide a rapidly changingmagnetic field of at least 500-600 Tesla/second.
 4. Apparatus accordingto claim 1 wherein the computerized controller is configured to provideintermittent oscillatory stimulation, wherein the rapidly changingmagnetic field is applied for a stimulus period of a given duration,wherein the stimulus period has a repetition rate of a given frequency,and further wherein the stimulus periods are separated by periods ofsubstantial quiet.
 5. Apparatus according to claim 4 wherein thestimulus period has a duration of 1-500 ms.
 6. Apparatus according toclaim 4 wherein the stimulus period has a repetition rate of 0.1-10 Hz.7. Apparatus according to claim 1 wherein the computerized controller isconfigured to provide continuous oscillatory stimulation, wherein therapidly changing magnetic field is applied continuously throughout theduration of a stimulation session.
 8. Apparatus according to claim 1further comprising a plurality of electrodes for monitoring theelectrical activity of the brain.
 9. A method for providing TranscranialMagnetic Stimulation (TMS) to an individual, the method comprising:providing apparatus comprising: a head mount for disposition on the headof an individual; a plurality of magnet assemblies for releasablemounting on the head mount, wherein each of the magnet assembliescomprises a permanent magnet, and at least one of (i) a movementmechanism for moving the permanent magnet and/or (ii) a magnetic shieldshutter mechanism, whereby to provide a rapidly changing magnetic field;and a computerized controller for operating at least one of the movementmechanism and the magnetic shield shutter mechanism of at least one ofthe magnet assemblies so as to apply a rapidly changing magnetic fieldto the brain of the individual, wherein the computerized controller isconfigured to operate at least one of the movement mechanism and themagnetic shield shutter mechanism of the at least one of the magnetassemblies so as to provide intermittent oscillatory stimulation and,simultaneously, to operate at least one of the movement mechanism andthe magnetic shield shutter mechanism of at least one of the magnetassemblies so as to provide continuous oscillatory stimulation, wherebyto induce weak electric currents in the brain of an individual so as tomodify the natural electrical activity of the brain of the individual;positioning the head mount on the head of the individual, andpositioning a selected number of magnet assemblies on the head mount atselected locations; and selectively providing a rapidly changingmagnetic field with at least one of the magnet assemblies.
 10. A methodaccording to claim 9 wherein the computerized controller operates atleast one of the movement mechanism and the magnetic shield shuttermechanism of a plurality of the magnet assemblies in a coordinatedfashion so as to induce the desired weak electric currents in the brainof an individual so as to modify the natural electrical activity of thebrain of the individual.
 11. A method according to claim 9 wherein eachof the magnet assemblies is configured to provide a rapidly changingmagnetic field of at least 500-600 Tesla/second.
 12. A method accordingto claim 9 wherein the computerized controller is configured to provideintermittent oscillatory stimulation, wherein the rapidly changingmagnetic field is applied for a stimulus period of a given duration,wherein the stimulus period has a repetition rate of a given frequency,and further wherein the stimulus periods are separated by periods ofsubstantial quiet.
 13. A method according to claim 12 wherein thestimulus period has a duration of 1-500 ms.
 14. A method according toclaim 12 wherein the stimulus period has a repetition rate of 0.1-10 Hz.15. A method according to claim 9 wherein the computerized controller isconfigured to provide continuous oscillatory stimulation, wherein therapidly changing magnetic field is applied continuously throughout theduration of a stimulation session.
 16. A method according to claim 9further comprising a plurality of electrodes for monitoring theelectrical activity of the brain.